Thompson v Accident Compensation Corporation

IE DISTRICT HELD AT AUCKLAND Decision No. 181 /2008 IN THE MATTER of the Injury Prevention, Rehabilitation and Compensation Act 2001 AND IN THE MATTER of an appeal pursuant to Section 149 of the Act BETWEEN CHARLOTTE THOMPSON (Al 484/06) Appellant AND ACCIDENT COMPENSATION ORATION Respondent HEARD at AUCKLAND on 17 July 2008 APPEARANCES Ms C Thompson in person, Ms C Campbell, Counsel for Respondent. RESERVED JUDGMENT OF JUDGE M J BEATTIE [1] The issue in this appeal arises from the respondent's decision of 10 October 2005, whereby it declined to grant cover to the appellant for personal injury arising from medical misadventure, being medical mishap. [2] It should be recorded that the appellant had initially sought cover for three medical conditions claimed to have arisen by reason of medical misadventure, the first condition being that of Central Neural Sympathetic Sensitisation Disorder (Chronic Pain Syndrome); secondly, liver damage consequent upon the prescription and use of the drug Danazol, and thirdly, the unconsented removal of her left ovary, surgical menopause and backpain. 484.06 (pg) 2 (3] The respondent's primary decision considered all three of those medical conditions, as had its Medical Misadventure Unit, and the decision of 10 October 2005 declined cover in respect of all three. [4] When the appellant sought a review of that decision, she had modified her claim to that of personal injury by medical mishap, being abnormal liver function tests secondary to the prescribing of the drug Danazol. (5] The Review Decision now appealed to this Court determined that the abnormal liver function tests of themselves did not demonstrate evidence of a physical injury causally linked to Danazol. [6] It is the respondent's position that the condition of the appellant's liver, as identified in liver function tests, does not constitute a physical injury, but that in any event the appellant cannot satisfy the statutory criteria for medical mishap. [7] One of the medical specialists on whom the appellant is relying is Professor Carl Burgess, Professor of Medicine/Clinical Pharmacology, and in his report of 4 May 2005, he sets out the appellant's clinical background to the matters which arise in this claim. He stated as follows: "This patient is known to have endometriosis that was originally diagnosed in 1999. She received a six-month course of danazol that, according to the chart provided by the claimant, was at a dose of 400 mg daily. After the course was St was stopped in February 2000, pain recurred and she was treated with a further course of danazol at 600 mg ontinued until December 00 when surgery. She had a further course of danazol in April 2001 when she received a dose of 800 mg daily up until the end of June 2001 when she underwent further surgery. Thereafter she received no further danazol. In regard to her liver function tests, apparently she had normal liver function in 1998 although that record has not been passed on to me. However, it is commented on by both Dr Rose and Dr Gane who have both provided reports. The liver function tests became abnormal in November 2001. The pattern of abnormality was elevation in the alkaline phosphatase, GGT and ALT. The tests themselves were not markedly abnormal. An example from 12 February 2003 showed an alkaline phosphatase of 137 normal is 25-100), GGT 164 (normal is 0-50), ALT 89 (normal is 0-40), AST 54 (normal is 0-45). These can be compared with liver function tests performed in December 2001 when the alkaline phosphatase was 227, GGT 266, ALT 166 and AST 128. There has been some resolution as time has gone by. This patient went forward for a liver biopsy after she'd been shown to have positive anti- mitochondrial antibodies suggesting primary biliary cirrhosis. The biopsy occurred on 29 August 2003 and the report notes that the appearances were those of steatohepatitis. There was additional ductal abnormalities which are consistent with, 3 although not diagnostic of, early primary biliary cirrhosis. The patient was then placed on Actigal which is used in patients with primary biliary cirrhosis. According to Or Gane's report, liver function tests were repeated in 2005 and are now normal. He also noted that on an abdominal ultrasound there had been significant fatty infiltration of the liver which was not present on the ultrasound performed in January 2002. There was also evidence of weight gain over the last three years. These are the circumstances of this claim." (8] It should be noted that Danazol is a well recognised drug prescribed for the medical condition known as endometriosis. Professor Burgess has also commented on the prescription of Danazol, at the time of so doing his comments were directed at issues of medical error. He commented as follows: "This patient received three courses of danazol. The dose varied between 400 mg and 800 mg per day. This is the recommended dosing for this substance. It is usual for danazol to be recommended for a six to nine-month course. However, this has to be tempered by the patient's illness. It is noted that she responded each time to danazol in that it relieved some of her symptoms. Following the first course of treatment, her condition relapsed when the danazol was stopped and so it was not too surprising that ctor restarted it again. I note that it was stopped when she went forward to surgery and then was restarted for a period when symptoms recurred post-surgery. I think that under such circumstances it is not unusual for a patient to receive additional courses of danazol. Therefore I do not think medical error has occurred here." [9] As was noted by Professor Burgess, the appellant was diagnosed with primary biliary cirrhosis and it need only be said that this particular condition was not caused by the drug Danazol but was a condition which did arise and caused its own separate and significant liver problems. [10] The appellant lodged her claim for cover in June 2003, following which the respondent's Medical Misadventure Unit sought reports from specialists who had been involved in her treatment as well as seeking independent specialist opinion. It is to be remembered that the claim for cover was much broader than that which is now the issue before the Court [11] At the time the appellant lodged her claim she had been referred to Dr Toby Rose, Gastroenterologist, by her GP, and he provided a report dated 30 July 2003 to Dr Anderson, and a copy to the Medical Misadventure Unit. His report, which was done without the benefit of the results of the laboratory tests which he had directed, identified that he suspected that the appellant had primary biliary cirrhosis, and this was an explanation for the slowly increasing disturbance of her liver function tests. He indicated he would report further following the laboratory test results, but did note that in his opinion the Danazol was not likely to be a cause of her liver disease 4 [12] In a further report dated 19 September 2003, Or Rose advised that the appellant's liver biopsy results suggested early primary biliary cirrhosis and that the other feature was that of steato hepatitis, commonly known as fatty liver disease. He then stated: "This is also likely to be contributing to her abnormal liver function tests, tiredness and right upper quadrant discomfort. While fatty liver can be caused by medications and toxins such as alcohol, the most likely cause in Charlotte's case would be her recent weight gain. Generally when it is caused by toxins it resolves when the toxins are removed which would make me less convinced that the Danazol was driving the fatty liver. It has been some time since she has taken Danazol. She has gained a lot of weight over the last year or so." [13] The next specialist to report to the Medical Misadventure Unit was Dr Paul Dempsey, Obstetrician and Gynaecologist. In his report of 13 October 2003, he gave a full review of her medical history and much of his report is discussing medical issues which are no longer relevant, but one matter which is of relevance is his opinion that the liver damage identified was unlikely to have been due to Danazol. [14] In a letter dated 10 November 2003, Dr Rose responded to a request from the appellant, who had provided him with details of her weight at various points in time from October 1999 onwards. Dr Rose then noted as follows: "I do not have any liver function tests available to me from October 1999. I do have a set from February 1998 but do not have a weight corresponding to that. It would also be unclear whether you would have had any early manifestation of your primary biliary cirrhosis at that stage. It is therefore difficult to offer a clear interpretation of this information. I note that the liver function tests were mildly disturbed in November 2001 when your weight was 67 kgs, but I do not appear to have a record of them from December 2002 when your weight was 80 kgs. Your liver function tests will fluctuate for a number of reasons. Even in individuals with constant weight with known fatty liver, there is some day to day fluctuation of liver function tests for a multitude of reasons, some of which are understood and some of which are not understood. From this information, I could not conclusively say that the disturbed liver function tests were not related to your fatty liver. I am still left with the opinion that I had expressed previously, which is that they are likely to relate to primary biliary cirrhosis and fatty liver and less likely to relate to medication you are on and that the nature of the disturbed liver function tests associated with the medication would generally be transient in that it would resolve when the medications were withdrawn. This opinion is of the most likely explanation. There can never be absolute certainty because of the multitude of factors coming into play here. " [15] A second opinion from a gastroenterologist was sought by the Medical Misadventure Unit, and it received a report from Dr Peter Johnston in that regard. Dr Johnston had the previous reports for reference and he commented, inter alia, as follows: 5 "The history of Danazol use is summarized in Or Rose's letters, and also in Mr Dempsey's report. Liver tests were noted to have been normal in 1998, before the use of his drug, and were then mildly abnormal in November 2001. Dr Rose in his initial consultation considered various possible liver pathologies, including fatty infiltration (steatohepatitis) and primary biliary cirrhosis. Danazol was thought unlikely to have been underlying the altered liver tests. Antimitochondrial antibodies, which are specific for primary biliary cirrhosis were positive and this led to a liver biopsy being done. This showed severe fat infiltration and bile duct lesions compatible with but not exclusive to the early stages of primary biliary cirrhosis. Dr Rose concluded that the altered liver tests and the fat infiltration were unlikely to be due to the Danazol, although one could never be entirely sure. I have reviewed literature on the liver effects of Danazol. It is clear that reversible changes in liver blood tests can occur, but the histological changes associated with this are not defined. Fat infiltration is not a recognized effect of Danazol; as Dr Rose points out, this problem is found in many different situations and in many cases the cause is not clear. It is possible, however, that Danazol could have had an influence in this case but no more specific comment can be made. Primary biliary cirrhosis is an immunological disease of unknown origin but it is not recognized as being caused by any drugs.' [16] Following a Reviewer referring the matter back to the respondent for further investigation in his decision of 24 February 2005, the respondent sought the opinion of Associate Professor Ed Gane. Dr Gane saw and examined the appellant at the Hepatitis Clinic at Middlemore Hospital and reported to the Medical Misadventure Unit on 17 February 2005, his report stating, inter alia, as follows: 'There is no doubt that she has primary biliary cirrhosis, although this is at a very early stage. With appropriate therapy (Actigal) she should never progress to cirrhosis or the complications thereof. There is clear evidence that she first developed abnormal liver function tests whilst aking Danazol therapy. Certainly this can cause acute hepatitis, but this usually resolves following withdrawal of treatment. It is impossible to prove whether or not this therapy precipitated the onset of primary biliary cirrhosis, which was first diagnosed in this woman in August 2003 following a liver biopsy. Her previous courses of Danazol therapy were between October 1999 and December 2001. The liver function tests in February 1998 were entirely normal, but became abnormal in November 2001. They have only recently normalised since the introduction of Actigal (which improves liver dysfunction no matter what the cause may be). In addition, this woman has other auto-immune conditions including limited scleroderma. To summarise, certainly her Danazol therapy may have caused abnormal liver function tests between 1999 and 2002 but it is unlikely to cause chronic liver disease or primary biliary cirrhosis or any subsequent auto-immune liver disease." [17] In his attached clinic letter, Professor Gane stated, inter alia, as follows: 6 Charlotte is concerned that her previous Danazol therapy may have resulted in her chronic liver condition, and in her other auto-immune conditions. Although Danazol can certainly cause liver dysfunction during treatment, it seems unlikely that this would precipitate the onset of primary biliary cirrhosis or other auto- immune conditions." [18] The next specialist requested to provide an independent medical opinion was Professor Carl Burgess. In addition to the passages from his report earlier quoted, he was posed two questions and his answers to same are as follows: Q. Has a physical injury occurred as a result of treatment? A. This patient has developed abnormal liver function tests. Whether they relate to danazol or to the biliary cirrhosis is difficult to ascertain. It is highly likely that if they were due to danazol then they would have got better with withdrawal of the drug. There is no reference in the literature to danazol itself causing primary biliary cirrhosis. The biopsy would suggest that this is the most likely diagnosis. However, I was impressed by the fact that the liver function tests were worse in 2001 than they were in 2003 and I would think that it was likely that danazol did play a role in the initial abnormal liver function tests, but I do not believe that it is a cause of primary biliary cirrhosis. Q. Does the claim meet the criteria for medical mishap? A The pattern of change in liver function tests would suggest that hepatotoxicity has occurred. Though I do not doubt the occurrence of primary biliary cirrhosis, I think it would be unusual for it to have been associated with the pattern of response noted hero. I do not have a problem with it returning to normal since the use of Actigal. Therefore I would think that there may very well have been a period before the Actigal was started, but from the time of the abnormal liver function tests between 2001 and 2003 when the abnormal liver function tests may very well have been related to the use of danazol. It is noted, however, that she was taking a lot of other compounds as well, some of which are also hepatotoxic. Taking this into account, the abnormal liver function tests were certainly abnormal for a period greater than 28 days. She also felt tired and lethargic which are common symptoms associated with liver disorders. Furthermore, abnormal liver function tests with danazol are rare and certainly occur in less than 1% of patients. Therefore, if one accepts that the abnormal liver function tests are due to danazol, then this claim would meet the criteria for medical mishap." [19] Professor Burgess gave his opinion as follows: "In my opinion there has been two problems with her liver. One does relate to hepatotoxicity and the most likely cause is danazol. Secondly is the occurrence of the primary biliary cirrhosis that I do not think is related to the danazol at all. Therefore I think this claim should be accepted for medical mishap." [20] The next specialist who provided independent advice to the Medical Misadventure Unit was Dr Andrew Harrison, Rheumatologist. He was provided with all the earlier reports, including those of Professor Gane and Dr Rose. In his report dated 17 July 2005, he noted the extensive history and in answer to the question, "Did treatment with Danazol cause liver injury?" he stated as follows: 7 "With respect to the liver function abnormalities it is difficult to come to clear conclusions about the cause of the initial abnormalities in 2001, and the timing of the onset of primary biliary cirrhosis. Danazol is known to cause liver function abnormalities, but the treatment with danazol had ceased six months before the recorded peak in liver enzymes. There does not appear to be any record of liver function during the period of treatment with danazol. In view of the fact that alkaline phosphate was consistently elevated, whereas AST and ALT were only intermittently raised, it is certainly possible that the liver function picture reflects cholestasis (as would be seen in PBC) rather than the hepatotoxic picture of a drug reaction. Ultimately, the following points are relevant. 1) The liver function abnormalities persisted for two years after the last course of danazol. 2) The liver biopsy and anti-mitochondrial antibodies point to primary biliary cirrhosis and steatohepatitis rather than drug toxicity. 3) Even if it were clear that danazol had caused the liver function abnormalities, symptoms would be unlikely at this low level of dysfunction, so the criterion of severity would not be met. 4) There is no reason to believe that danazol was responsible for the development of PBC. A search of the 1966 to present day Medline database combining the keywords "primary biliary cirrhosis" and "danazol" did not bring up any results. In my opinion, treatment with danazol has not resulted in injury." [21] Dr Harrison's report was referred to Professor Burgess for comment and he commented as follows in a letter to the Medical Misadventure Unit dated 1 September 2005. "The claim can be subdivided into the initial findings of the abnormal liver function tests (LFTS) and the final diagnosis of primary biliary cirrhosis (PBC). The initial abnormality was of a mixed hepatic and obstructive disorder. This type of disorder tends to take longer to heal than acute hepatic dysfunction associated with the use of medications. There was evidence of improvement between December 2001 and February 2003. Could the entire illness be associated with the abnormal LFTs be due to PBC? I think this is unlikely as PBC does not usually improve spontaneously. Therefore I still hold with 'd with my original opinion. There is no evidence that danazol was responsible for the final development of PBC." [22] As a wrap-up, and before the respondent made its primary decision, which is now the subject of this appeal, it referred all the medical reports to its Medical Advisor, Dr P Jansen, and from those reports he distilled the following "There is no scientific evidence that danazol causes primary biliary cirrhosis. Danazol can cause liver dysfunction and may have done so in the case of Ms Thompson. However any dysfunction would subside once the danazol was stopped and this has been noted by the expert advisors who provided reports to ACC. In particular it was noted that the peak in liver enzyme abnormalities occurred some six 8 months after danazol was stopped and the pattern of test results did not suggest a drug reaction (hepatotoxic picture alone) but rather a mixed cholestatic and hepatotoxic picture. This strongly points to some other cause for the persisting liver dysfunction. (See for example the 1A reports of Burgess and Harrison). Furthermore as Prof Burgess notes (report of 04/05/2005) there are a number of other medications that could have caused a liver dysfunction aside from the danazol. In any case any liver dysfunction that may have been caused by danazol subsided when it was withard withdrawn and the expert opinion (and scientific evidence) does not support a causal role for the danazol in any persisting liver dysfunction." [23] In her submissions to the Court, the appellant contended that the hepatic effects which the liver function tests identified, and which were commented on by Professor Burgess, were sufficient to identify a physical injury to the liver. She further submitted that Professor Burgess had considered the criteria necessary to establish medical mishap and that his opinion was that such criteria had been satisfied. [24] Ms Thompson further submitted that the evidence of the specialists was to the effect that the primary biliary cirrhosis was not a drug induced liver disease, but that nevertheless Danazol had caused liver disease prior to the onset of PBC. [25] Ms Campbell, Counsel for the Respondent, submitted that there was not sufficient evidence of physical damage to the liver, and that the tests themselves were not evidence. [26] Counsel further submitted that even if liver damage be accepted, the criteria of severity could not be made out, and there was no evidence of any matters which would satisfy Section 34(2) of the Act, the only evidence being that of the appellant herself complaining of lethargy. Counsel further noted that any damage was only transitory and that by 2005 her liver function had returned to normal. DECISION [27] This appeal requires consideration of the statutory provisions pertaining to the claim for cover for personal injury caused by medical mishap. [28] As earlier noted, the appellant lodged her claim for cover in June 2003, and as such her claim is governed by the provisions of the Injury Prevention, Rehabilitation and Compensation Act 2001, that were in force at that time. 9 [29] Section 32 of the Act as it then was allowed for cover for personal injury caused by medical misadventure, being either medical error or medical mishap. Section 34 of the Act defines medical mishap, and paraphrasing that provision it means personal injury which is an adverse consequence of treatment properly given and the adverse consequence is both severe and rare. Section 34(2) defines "severe" as meaning: (a) dying; or (b) being hospitalised as an in-patient for more than 14 days; or (c) suffering a restriction or lack of ability that - (i) is significant; and (ii) prevents the person from performing an activity in the manner or within the range considered normal for the person; and (ili) lasts more than 28 days in total." "Rarity" is defined in subsection (3) as where: 'The likelihood that treatment of the kind that was given would have the adverse consequence if the probability is that the adverse consequence would not occur in more than 1% of cases in which that treatment is given." [30] The first matter which needs to be established is whether or not the appellant has suffered a physical injury to her liver, that being the injury asserted. [31] It seems to be accepted that in November 2001 and at times subsequent, liver function tests carried out identified abnormality in the appellant's liver function. It was stated by Professor Burgess to be an elevation in the alkaline phosphatase, GGT and ALT. It seems that he is the only person who has commented on what the abnormality in fact was, all other specialists simply noting the fact of abnormal liver function tests and which seemed to be a prelude to the onset of primary biliary cirrhosis [32] However, Professor Burgess did identify that hepatotoxicity had occurred to the liver. He further identified the condition as being an abnormality which was a mixed hepatic and obstructive disorder. [33] It must be accepted that the appellant's liver was affected so that it was not functioning normally, and I find as a fact that the state of the appellant's liver, as of November 2001, was such that it constituted a physical injury. 10 [34] Turning now to the criteria of "rarity" and "severity", as required by Section 34, the only specialist who has commented on this is Professor Burgess and who advised that abnormal liver function tests attributable to Denazol were rare and certainly occur in less than 1% of patients. [35] It seems that the respondent accepted Professor Burgess' report as it did not seek to have any other specialists comment on the question of rarity, even though Dr Harrison did comment on the question of severity. It is fair to say that Dr Harrison was of the opinion that Denazol had not resulted in injury, but when he gave that opinion | doubt whether he would have been appraised of the legal test of physical injury for the purposes of the Act. [36] Counsel for the Respondent did not address this issue of rarity other than to note that only Professor Burgess had commented on the question of rarity. [37] In the absence of any evidence to the contrary, I find that the opinion expressed by Professor Burgess must be accepted and therefore the criteria of rarity has been satisfied. [38] Turning now to the test of severity, as required by Section 34(2), the only positive evidence would seem to be that the period within which the appellant demonstrated abnormal liver function, as identified by tests, was for a period greater than 28 days. However, as Professor Burgess noted, the only physical effects of the abnormal liver function identified by the appellant, was a feeling of tiredness and lethargy, symptoms which he noted were common to other liver disorders. [39] The appellant herself did not take the matter to any greater degree of severity than to reaffirm the statements noted by Professor Burgess. There is no evidence of her requiring medical treatment for any consequences of liver abnormality. In this case, I find that the observation made by Or Harrison encapsulates the position, where he noted: 'Even if it were clear that Danazol had caused the liver function abnormalities, symptoms would be unlikely at this low level of dysfunction, so the criterion of severity would not be met." Accordingly, I find that the test of severity has not been satisfied and therefore one of the statutory criteria necessary to obtain cover has not been met and the claim for cover must therefore fail. 11 [40] For the foregoing reasons, therefore, this appeal is dismissed. DATED this 14 day of August 2008 M J Beattie District Court Judge